Supporting and Enhancing NICU Sensory Experiences (SENSE) (SENSE)

• ClinicalTrials.gov Identifier: NCT03316547
• Recruitment Status: Completed
• First Posted: October 20, 2017
• Results First Posted: July 7, 2021
• Last Update Posted: July 7, 2021
• Sponsor: Washington University School of Medicine
• Collaborator: University of Southern California
• Information provided by (Responsible Party): Washington University School of Medicine

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Care Provider, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Premature Birth of Newborn
• Intervention: Other: SENSE Program
• Enrollment: 70

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Control	Intervention
Arm/Group Description	The control group received standard hospital care.	Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable. SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant.
Period Title: Overall Study
Started	39	31
Completed	21	18
Not Completed	18	13
Reason Not Completed
Death	3	1
Lost to Follow-up	6	6
Withdrawal by Subject	3	2
Transfer to another hospital	6	4

Baseline Characteristics

Arm/Group Title		Control	Intervention	Total
Arm/Group Description		The control group received standard hospital care.	Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable. SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant.	Total of all reporting groups
Overall Number of Baseline Participants		39	31	70
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	39 participants	31 participants	70 participants
	<=18 years	39 100.0%	31 100.0%	70 100.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: EGA at birth (weeks)
	Number Analyzed	39 participants	31 participants	70 participants
		29.5 (2.5)	29.7 (2.6)	29.6 (2.5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	39 participants	31 participants	70 participants
	Female	28 71.8%	19 61.3%	47 67.1%
	Male	11 28.2%	12 38.7%	23 32.9%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	39 participants	31 participants	70 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	10 25.6%	13 41.9%	23 32.9%
	White	0 0.0%	0 0.0%	0 0.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	29 74.4%	18 58.1%	47 67.1%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	39 participants	31 participants	70 participants
		39 100.0%	31 100.0%	70 100.0%

Outcome Measures

1. Primary Outcome

Title	Ages and Stages Questionnaire (ASQ) - Communication at 1 Year
Description	Parents completed the parent-report measure of child development, the Ages and Stages Questionnaire (ASQ), at 1 year corrected age. The ASQ The Communication subscore is the primary variable of interest, which looks at the child's language and communication skills at time of assessment. Higher scores on the ASQ Communication subsection indicate more positive outcomes. A child can score a minimum of 0 points and a maximum of 60 points on the Communication subscale.
Time Frame	One year corrected age

Outcome Measure Data

Analysis Population Description

As noted in Participant Flow module, overall number of participants analyzed reflects participants who completed testing at 1 year follow-up (decrease in participants due to death, transfer, and loss to follow-up).

Arm/Group Title	Control	Intervention
Arm/Group Description:	The control group received standard hospital care.	Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable. SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant.
Overall Number of Participants Analyzed	21	18
Mean (Standard Deviation); Unit of Measure: score on a scale
	38.6 (18.1)	48.6 (10.3)

2. Primary Outcome

Title	Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) Excitability Score at Term Equivalent Age
Description	Infants were assessed using the NICU Network Neurobehavioral Scale (NNNS) by a blinded evaluator. The Excitability subscore, which measures state-related level of arousal over the course of the whole examination, is the primary variable of interest, and ranges from 1-8. An average response falls in the moderate, midpoint range (4-5), and describes an infant who could be brought to respond to stimuli in spite of a high degree of upset or excitement, but then can return to moderate state. Thus, a midpoint range score (4-5) would indicate a better outcome on the Excitability sub scale, whereas a lower (<4) or higher (>5) score would indicate a worse outcome.
Time Frame	At term equivalent age (35-41 weeks PMA)

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed reflects number of participants assessed at term equivalent age (some were lost at this time point for this assessment due to death or transfer to a different hospital).

Arm/Group Title	Control	Intervention
Arm/Group Description:	The control group received standard hospital care. N = 39	Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable. SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant. N = 31
Overall Number of Participants Analyzed	28	24
Mean (Standard Deviation); Unit of Measure: score on a scale
	4.4 (2.7)	4.1 (2.2)

3. Secondary Outcome

Title	Language Environmental Acquisition Device (LENA)
Description	Audio recordings of a single 16 hour period to capture language and sound exposure occurred at 34 weeks using the Language Environmental Acquisition Device (LENA). The LENA device is a digital language processor that captures environmental sound for up to 16 hours and quantifies: % of the recording with meaningful word exposure, % of the recording with electronic noise, % of the recording with noise, % of the recording with silence, and % of the recording with distant word exposure.
Time Frame	Single 16 hour period to capture language and sound exposure will occur at 34 weeks to assess treatment fidelity/differentiation.

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed reflects number of participants assessed at 34 weeks (some were lost at this time point for this assessment due to death or transfer to a different hospital or inability to complete recording due to technological or administrative issues).

Arm/Group Title	Control	Intervention
Arm/Group Description:	The control group received standard hospital care.	Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable. SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant.
Overall Number of Participants Analyzed	17	12
Mean (Standard Deviation); Unit of Measure: percentage of 16h recording
% Meaningful words	2.4 (1.5)	3.9 (3.0)
% Distant words	2.6 (2.6)	3.7 (2.6)
% TV or electronic sounds	14.8 (14.0)	14.3 (17.4)
% Noise	12.5 (9.7)	10.2 (9.1)
% Silence	67.7 (17.8)	68.0 (18.5)

4. Secondary Outcome

Title	Sensory Exposures Provided During Hospitalization
Description	During each day of hospitalization (from day of consent, often within 1 week of birth, to day of discharge, often near term-equivalent age; an average of about 2 months), parents, health care professionals and the sensory support team documented the type and amount of tactile and auditory exposures conducted. The proportion of the SENSE program doses, whether parents conducted the majority of the sensory exposures and whether the doses were met were defined after hospital discharge was complete.
Time Frame	Sensory exposures were documented every day of hospitalization (from birth to term-equivalent age; an average of about 2 months).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description:	The control group received standard hospital care. N = 39	Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable. SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant. N = 31
Overall Number of Participants Analyzed	28	24
Measure Type: Count of Participants; Unit of Measure: Participants
# of infants who received > 75% of recommended doses of sensory interventions	14 50.0%	24 100.0%
# of infants who received 100% of recommended doses of sensory interventions	8 28.6%	15 62.5%
Parent provided > 50% of interventions received	12 42.9%	12 50.0%

5. Secondary Outcome

Title	Dubowitz/Hammersmith Neonatal Neurological Evaluation
Description	At the NICU bedside, infant neurobehavior was assessed by a blinded evaluator using the Dubowitz/Hammersmith Neonatal Neurological Evaluation (HNNE). The HNNE is an assessment of neonatal neurological status. The total score is used as an outcome variable and ranges from 0-78. A higher score indicates a better outcome, whereas a lower score indicates a worse outcome.
Time Frame	At term equivalent age (between 35-41 weeks post menstrual age), just prior to discharge from the hospital.

Outcome Measure Data

Analysis Population Description

The number of participants analyzed reflects the number of infants who underwent HNNE assessment at 35-41 weeks post menstrual age; some infants were not assessed at this time point due to death or transfer to a different hospital prior to NICU discharge.

Arm/Group Title	Control	Intervention
Arm/Group Description:	The control group received standard hospital care.	Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable. SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant.
Overall Number of Participants Analyzed	28	24
Mean (Standard Deviation); Unit of Measure: score on a scale
	22.8 (4.0)	20.6 (3.4)

6. Secondary Outcome

Title	General Movement Assessment (GMA)
Description	A video recording was conducted to enable scoring of general movements and infant neurological/motor status using the General Movements Assessment. However, video quality was deemed insufficient for analysis.
Time Frame	At term equivalent age (between 35-41 weeks post menstrual age), just prior to discharge from the hospital.

Outcome Measure Data

Analysis Population Description

Video quality was insufficient for appropriate scoring and thus not analyzed.

Arm/Group Title	Control	Intervention
Arm/Group Description:	The control group received standard hospital care.	Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable. SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

7. Secondary Outcome

Title	Discharge Questionnaire
Description	Prior to discharge from the hospital, the infant's mother completed a questionnaire. Measures included the Sensory Profile-2 (SP-2), the State Trait Anxiety Inventory (STAI), the Edinburgh Postnatal Depression Scale (EPDS), the Parent Stress Index (PSI), The Parental Stress Scale: NICU (PSS), the Maternal Confidence Questionnaire, and the Infant Care Questionnaire (ICQ). The SP-2 assesses infant sensory processing skills with summary scores for tactile, auditory, visual, movement, oral, and general processing. The STAI measures maternal anxiety separated into state-related and trait-related anxiety. The PSI includes subscales to measure defensive responding, parental distress, parent-child dysfunctional interaction, & difficult child behaviors. The ICQ measures maternal connection, emotionality, and responsiveness. Possible score ranges and directions of scores listed with each variable below.
Time Frame	Just prior to discharge from the hospital (between 35-41 weeks post menstrual age).

Outcome Measure Data

Analysis Population Description

Questionnaires were included if complete; number of participants analyzed reflects number of completed questionnaires. Reasons for questionnaire incompletion were: infant death, transfer prior to discharge.

Arm/Group Title	Control	Intervention
Arm/Group Description:	The control group received standard hospital care.	Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable. SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant.
Overall Number of Participants Analyzed	28	24
Mean (Standard Deviation); Unit of Measure: score on a scale
Sensory Profile - Touch (range 3-15) - higher = possible dysfunction	4.3 (1.8)	4.8 (2.1)
Sensory Profile - Auditory (range 4-20) higher = possible dysfunction	9.2 (3.7)	8.1 (3.4)
Sensory Profile - Visual (range 4-20)higher = possible dysfunction	6.7 (4.0)	5.6 (2.8)
Sensory Profile - Movement (range 4-20) higher = possible dysfunction	8.0 (2.0)	7.9 (2.4)
Sensory Profile - Oral (range 2-10) higher = possible dysfunction	4.6 (1.9)	4.2 (1.7)
Sensory Profile - General (range 8-40) higher = possible dysfunction	14.1 (5.7)	14.9 (5.6)
PSI- Defensive Responding (range 7-35) Higher = more dysfunction	13.3 (5.4)	13.0 (6.1)
PSI - Parental Distress (range 12-60) Higher = more dysfunction	22.7 (7.7)	22.6 (10.0)
PSI - Parent-Child Dysfunctional Interaction (range 12-60) Higher = more dysfunction	19.6 (5.4)	18.7 (7.5)
PSI - Difficult Child (range 12-60) Higher = more dysfunction	18.2 (5.2)	17.4 (5.7)
Edinburgh Postnatal Depression Scale (range 0-30) Higher = more likelihood of depression	9.0 (4.7)	8.5 (5.5)
Parental Stressor Scale - NICU (range 0-5), Higher = more stress	3.1 (1.2)	2.5 (1.0)
STAI - State Anxiety (range 20-80) Higher = more anxiety	38.5 (11.9)	35.1 (17.9)
STAI - Trait Anxiety (range 20-80) Higher = more anxiety	37.0 (11.5)	34.8 (14.7)
Maternal Confidence Questionnaire (range 0-56) Higher = more stress	44.2 (9.0)	49.1 (7.6)
ICQ - Mom and Baby (range 0-5), Higher = better care	4.3 (0.5)	4.3 (0.8)
ICQ - Emotionality (range 0-5), Higher = better care	4.2 (0.9)	4.3 (0.9)
ICQ - Responsiveness (range 0-5), Higher = better care	3.7 (0.8)	4.1 (0.9)

8. Secondary Outcome

Title	1 Year Follow-Up Questionnaire
Description	The infant's mother completed a questionnaire with the following measures: the ASQ, SP-2, STAI, Beck Depression Inventory (BDI), PSI, Maternal Confidence Questionnaire (MCQ), ICQ, Pediatric Eating Assessment Tool (Pedi-eat), and Behavioral Pediatrics Feeding Assessment Scale (BPFAS). ASQ, SP-2, STAI, PSI, MCQ, and ICQ are previously described in discharge questionnaire outcome data. The BDI was used to measure maternal depression at time of follow-up. The Pedi-eat and BPFAS were used to assess infant feeding skills. Possible score ranges and directions of scores are reported below under each individual variable.
Time Frame	One year corrected age.

Outcome Measure Data

Analysis Population Description

Number of participants analyzed reflects the number of received follow-up questionnaires at 1 year corrected age. Participants who died, transferred to a different NICU prior to discharge, or did not complete follow-up questionnaires were not included.

Arm/Group Title	Control	Intervention
Arm/Group Description:	The control group received standard hospital care.	Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable. SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant.
Overall Number of Participants Analyzed	21	18
Mean (Standard Deviation); Unit of Measure: score on a scale
PSI - Defensive Responding (range 7-35), Higher = more dysfunction	11.9 (4.4)	11.7 (7.0)
PSI - Parental Distress (range 12-60), Higher = more dysfunction	20.8 (7.8)	20.6 (11.6)
PSI - Difficult Child (range 12-60), higher = more dysfunction	20.1 (6.3)	17.8 (8.1)
Beck Depression Inventory (range 0-63), Higher = more depression	3.6 (4.1)	3.9 (5.9)
STAI - State Anxiety (range 20-80), Higher = more anxiety	33.7 (9.6)	28.9 (9.0)
STAI - Trait Anxiety (range 20-80), Higher = more anxiety	35.8 (9.3)	28.8 (13.1)
Maternal Confidence Questionnaire (range 0-56), Higher = more confidence	51.4 (5.2)	52.4 (3.2)
ICQ - Mom and Baby (range 0-5), higher = better care	4.2 (0.9)	4.3 (0.9)
ICQ - Emotionality (range 0-5), higher = better care	4.1 (0.9)	3.8 (1.7)
ICQ - Responsiveness (range 0-5), higher = better care	4.5 (1.0)	4.6 (1.1)
ASQ - Communication (range 0-60), Higher = better	38.6 (18.1)	48.6 (10.3)
ASQ - Problem Solving (range 0-60), Higher = better	35.8 (20.4)	41.1 (14.2)
ASQ - Gross Motor (range 0-60), Higher = better	34.1 (22.6)	42.8 (19.6)
ASQ - Fine Motor (range 0-60), higher = better	46.5 (10.4)	47.8 (14.0)
ASQ - Personal-Social (range 0-60), higher = better	36.0 (17.8)	40.3 (16.4)
Sensory Profile - Touch (range 10-50), higher = more dysfunction	16.9 (6.2)	19.7 (4.3)
Sensory Profile - Auditory (range 7-35), Higher = more dysfunction	9.7 (4.6)	9.7 (5.0)
Sensory Profile - Visual (range 8-40), Higher = more dysfunction	22.0 (4.3)	21.6 (4.2)
Sensory Profile - Movement Processing (range 6-30), Higher = more dysfunction	18.8 (3.8)	20.3 (2.9)
Sensory Profile - Oral (range 7-35), higher = more dysfunction	11.4 (4.7)	10.6 (4.4)
Sensory Profile - General (range 10-50), Higher = more dysfunction	14.2 (6.6)	13.9 (6.1)
Sensory Profile - Behavior (range 6-30), Higher = more dysfunction	10.6 (5.3)	11.2 (3.6)
Pediatric Eating Assessment Tool (range 0-390), Higher = more dysfunction	54.1 (31.6)	61.2 (28.7)
Behavioral Pediatrics Feeding Assessment Scale (range 0-175), Higher = more dysfunction	55.4 (16.2)	51.0 (16.1)

9. Secondary Outcome

Title	Mother-Infant Interaction (at 1 Year Follow-up)
Description	At one year follow-up, mother-infant interaction will be assessed through the interaction subscale of the Parental Stress Index (PSI). A score in this subscale can range from 12-60, with higher scores indicating a greater degree of dysfunction.
Time Frame	One year corrected age.

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed reflects the number of participants who returned completed questionnaires at 1 year corrected age. Reasons for lack of completion included: death of infant, transfer to different hospital prior to NICU discharge, lost to follow-up (not responding to calls/mail).

Arm/Group Title	Control	Intervention
Arm/Group Description:	The control group received standard hospital care.	Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable. SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant.
Overall Number of Participants Analyzed	21	18
Mean (Standard Deviation); Unit of Measure: score on a scale
	17.8 (6.2)	14.3 (6.0)

10. Secondary Outcome

Title	Parent Engagement During Hospitalization
Description	On each day of hospitalization (from birth to discharge, which often occurred close to term equivalent age; for an average of about 2 months), parents, health care professionals and the sensory support team documented the frequency of parent visitation, holding, and skin-to-skin care.
Time Frame	Every day of hospitalization (from birth through discharge, often close to term equivalent age; on average about 2 months).

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed reflects total number of participants with complete bedside logs at time of NICU discharge. Some participants were lost due to death or hospital transfer prior to discharge.

Arm/Group Title	Control	Intervention
Arm/Group Description:	The control group received standard hospital care.	Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable. SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant.
Overall Number of Participants Analyzed	28	24
Mean (Standard Deviation); Unit of Measure: Days
Average number of days per 5-day week parents visited	3.9 (1.3)	3.9 (1.2)
Average number of days per 5-day week parents held infant	3.7 (1.1)	3.7 (1.3)
Average number of days per 5-day week parents provided skin-to-skin care	1.6 (1.6)	1.8 (1.7)

11. Secondary Outcome

Title	Language Environmental Acquisition Device (LENA) Adult Word Count
Description	Audio recordings of a single 16 hour period to capture language and sound exposure occurred at 34 weeks using the Language Environmental Acquisition Device (LENA). The LENA device is a digital language processor that captures environmental sound for up to 16 hours and can quantify the number of adult words spoken during the 16 hour recording.
Time Frame	Single 16 hour period to capture language and sound exposure will occur at 34 weeks to assess treatment fidelity/differentiation.

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed reflects number of participants assessed at 34 weeks (some were lost at this time point for this assessment due to death or transfer to a different hospital or inability to complete recording due to technological or administrative issues).

Arm/Group Title	Control	Intervention
Arm/Group Description:	The control group received standard hospital care. N = 39	Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable. SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant. N = 31
Overall Number of Participants Analyzed	17	12
Mean (Standard Deviation); Unit of Measure: words
	4618.1 (3934.0)	4338.5 (4818.8)

12. Secondary Outcome

Title	Percentage of Sensory Interventions Received
Description	Throughout hospitalization, parents, health care professionals and the sensory support team documented the type and amount of tactile and auditory exposures conducted. The percentage of recommended sensory doses that were received were documented.
Time Frame	Sensory exposures were documented every day of hospitalization (birth through discharge, often close to term) equivalent age).

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed reflects total number of participants with complete bedside logs at time of NICU discharge. Some participants were lost due to death or hospital transfer prior to discharge.

Arm/Group Title	Control	Intervention
Arm/Group Description:	The control group received standard hospital care.	Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable. SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant.
Overall Number of Participants Analyzed	28	24
Mean (Standard Deviation); Unit of Measure: percentage of interventions received
	80.5 (51.4)	122.7 (34.9)

Adverse Events

Time Frame	1 year, 6 months
Adverse Event Reporting Description	No adverse events reported.
Arm/Group Title	Control	Intervention
Arm/Group Description	The control group received standard hospital care.	Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable. SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant.
All-Cause Mortality
	Control	Intervention
	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/39 (7.69%)	1/31 (3.23%)
Serious Adverse Events
	Control	Intervention
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/39 (0.00%)	0/31 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Control	Intervention
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/39 (0.00%)	0/31 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Roberta Pineda
• Organization: Washington University
• Phone: 314-286-1304
• EMail: bobbi.pineda@chan.usc.edu

Publications of Results:

Pineda RG, Tjoeng TH, Vavasseur C, Kidokoro H, Neil JJ, Inder T. Patterns of altered neurobehavior in preterm infants within the neonatal intensive care unit. J Pediatr. 2013 Mar;162(3):470-476.e1. doi: 10.1016/j.jpeds.2012.08.011. Epub 2012 Oct 1.

Howe TH, Sheu CF, Wang TN, Hsu YW. Parenting stress in families with very low birth weight preterm infants in early infancy. Res Dev Disabil. 2014 Jul;35(7):1748-56. doi: 10.1016/j.ridd.2014.02.015. Epub 2014 Mar 19.

Singer LT, Fulton S, Kirchner HL, Eisengart S, Lewis B, Short E, Min MO, Satayathum S, Kercsmar C, Baley JE. Longitudinal predictors of maternal stress and coping after very low-birth-weight birth. Arch Pediatr Adolesc Med. 2010 Jun;164(6):518-24. doi: 10.1001/archpediatrics.2010.81.

Wraight CL, McCoy J, Meadow W. Beyond stress: describing the experiences of families during neonatal intensive care. Acta Paediatr. 2015 Oct;104(10):1012-7. doi: 10.1111/apa.13071. Epub 2015 Jun 26.

Bouet KM, Claudio N, Ramirez V, Garcia-Fragoso L. Loss of parental role as a cause of stress in the neonatal intensive care unit. Bol Asoc Med P R. 2012 Jan-Mar;104(1):8-11.

Heinemann AB, Hellstrom-Westas L, Hedberg Nyqvist K. Factors affecting parents' presence with their extremely preterm infants in a neonatal intensive care room. Acta Paediatr. 2013 Jul;102(7):695-702. doi: 10.1111/apa.12267. Epub 2013 May 8.

Anderson P, Doyle LW; Victorian Infant Collaborative Study Group. Neurobehavioral outcomes of school-age children born extremely low birth weight or very preterm in the 1990s. JAMA. 2003 Jun 25;289(24):3264-72. doi: 10.1001/jama.289.24.3264.

Anderson PJ, Doyle LW. Cognitive and educational deficits in children born extremely preterm. Semin Perinatol. 2008 Feb;32(1):51-8. doi: 10.1053/j.semperi.2007.12.009.

Holsti L, Grunau RV, Whitfield MF. Developmental coordination disorder in extremely low birth weight children at nine years. J Dev Behav Pediatr. 2002 Feb;23(1):9-15. doi: 10.1097/00004703-200202000-00002.

Goyen TA, Lui K, Woods R. Visual-motor, visual-perceptual, and fine motor outcomes in very-low-birthweight children at 5 years. Dev Med Child Neurol. 1998 Feb;40(2):76-81. doi: 10.1111/j.1469-8749.1998.tb15365.x.

Pineda RG, Neil J, Dierker D, Smyser CD, Wallendorf M, Kidokoro H, Reynolds LC, Walker S, Rogers C, Mathur AM, Van Essen DC, Inder T. Alterations in brain structure and neurodevelopmental outcome in preterm infants hospitalized in different neonatal intensive care unit environments. J Pediatr. 2014 Jan;164(1):52-60.e2. doi: 10.1016/j.jpeds.2013.08.047. Epub 2013 Oct 17. Erratum In: J Pediatr. 2015 Apr;166(4):1097.

Bystron I, Blakemore C, Rakic P. Development of the human cerebral cortex: Boulder Committee revisited. Nat Rev Neurosci. 2008 Feb;9(2):110-22. doi: 10.1038/nrn2252.

Burns CM, Rutherford MA, Boardman JP, Cowan FM. Patterns of cerebral injury and neurodevelopmental outcomes after symptomatic neonatal hypoglycemia. Pediatrics. 2008 Jul;122(1):65-74. doi: 10.1542/peds.2007-2822.

Berument SK, Sonmez D, Eyupoglu H. Supporting language and cognitive development of infants and young children living in children's homes in Turkey. Child Care Health Dev. 2012 Sep;38(5):743-52. doi: 10.1111/j.1365-2214.2011.01314.x. Epub 2011 Sep 27.

Daunhauer LA, Coster WJ, Tickle-Degnen L, Cermak SA. Effects of caregiver-child interactions on play occupations among young children institutionalized in Eastern Europe. Am J Occup Ther. 2007 Jul-Aug;61(4):429-40. doi: 10.5014/ajot.61.4.429.

Daunhauer LA, Coster WJ, Tickle-Degnen L, Cermak SA. Play and cognition among young children reared in an institution. Phys Occup Ther Pediatr. 2010 May;30(2):83-97. doi: 10.3109/01942630903543682.

Ellis BH, Fisher PA, Zaharie S. Predictors of disruptive behavior, developmental delays, anxiety, and affective symptomatology among institutionally reared romanian children. J Am Acad Child Adolesc Psychiatry. 2004 Oct;43(10):1283-92. doi: 10.1097/01.chi.0000136562.24085.160.

Other Publications:

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Seay B, Harlow HF. Maternal separation in the rhesus monkey. J Nerv Ment Dis. 1965 Jun;140(6):434-41. doi: 10.1097/00005053-196506000-00006. No abstract available.

Tottenham N, Hare TA, Quinn BT, McCarry TW, Nurse M, Gilhooly T, Millner A, Galvan A, Davidson MC, Eigsti IM, Thomas KM, Freed PJ, Booma ES, Gunnar MR, Altemus M, Aronson J, Casey BJ. Prolonged institutional rearing is associated with atypically large amygdala volume and difficulties in emotion regulation. Dev Sci. 2010 Jan 1;13(1):46-61. doi: 10.1111/j.1467-7687.2009.00852.x.

Tottenham N, Sheridan MA. A review of adversity, the amygdala and the hippocampus: a consideration of developmental timing. Front Hum Neurosci. 2010 Jan 8;3:68. doi: 10.3389/neuro.09.068.2009. eCollection 2009.

BRODBECK AJ, IRWIN OC. The speech behaviour of infants without families. Child Dev. 1946 Sep;17(3):145-56. No abstract available.

Govindan RM, Behen ME, Helder E, Makki MI, Chugani HT. Altered water diffusivity in cortical association tracts in children with early deprivation identified with Tract-Based Spatial Statistics (TBSS). Cereb Cortex. 2010 Mar;20(3):561-9. doi: 10.1093/cercor/bhp122. Epub 2009 Jun 22.

Aeby A, Van Bogaert P, David P, Baleriaux D, Vermeylen D, Metens T, De Tiege X. Nonlinear microstructural changes in the right superior temporal sulcus and lateral occipitotemporal gyrus between 35 and 43 weeks in the preterm brain. Neuroimage. 2012 Oct 15;63(1):104-10. doi: 10.1016/j.neuroimage.2012.06.013. Epub 2012 Jun 17.

Barre N, Morgan A, Doyle LW, Anderson PJ. Language abilities in children who were very preterm and/or very low birth weight: a meta-analysis. J Pediatr. 2011 May;158(5):766-774.e1. doi: 10.1016/j.jpeds.2010.10.032. Epub 2010 Dec 10.

Reynolds LC, Duncan MM, Smith GC, Mathur A, Neil J, Inder T, Pineda RG. Parental presence and holding in the neonatal intensive care unit and associations with early neurobehavior. J Perinatol. 2013 Aug;33(8):636-41. doi: 10.1038/jp.2013.4. Epub 2013 Feb 14.

Fanaroff AA, Kennell JH, Klaus MH. Follow-up of low birth weight infants--the predictive value of maternal visiting patterns. Pediatrics. 1972 Feb;49(2):287-90. No abstract available.

Latva R, Lehtonen L, Salmelin RK, Tamminen T. Visiting less than every day: a marker for later behavioral problems in Finnish preterm infants. Arch Pediatr Adolesc Med. 2004 Dec;158(12):1153-7. doi: 10.1001/archpedi.158.12.1153.

Ortenstrand A, Westrup B, Brostrom EB, Sarman I, Akerstrom S, Brune T, Lindberg L, Waldenstrom U. The Stockholm Neonatal Family Centered Care Study: effects on length of stay and infant morbidity. Pediatrics. 2010 Feb;125(2):e278-85. doi: 10.1542/peds.2009-1511. Epub 2010 Jan 25.

Krueger C, Parker L, Chiu SH, Theriaque D. Maternal voice and short-term outcomes in preterm infants. Dev Psychobiol. 2010 Mar;52(2):205-12. doi: 10.1002/dev.20426.

Diego MA, Field T, Hernandez-Reif M. Preterm infant weight gain is increased by massage therapy and exercise via different underlying mechanisms. Early Hum Dev. 2014 Mar;90(3):137-40. doi: 10.1016/j.earlhumdev.2014.01.009. Epub 2014 Jan 27.

Hernandez-Reif M, Diego M, Field T. Preterm infants show reduced stress behaviors and activity after 5 days of massage therapy. Infant Behav Dev. 2007 Dec;30(4):557-61. doi: 10.1016/j.infbeh.2007.04.002. Epub 2007 Jun 4.

Mendes EW, Procianoy RS. Massage therapy reduces hospital stay and occurrence of late-onset sepsis in very preterm neonates. J Perinatol. 2008 Dec;28(12):815-20. doi: 10.1038/jp.2008.108. Epub 2008 Jul 17.

Feldman R, Rosenthal Z, Eidelman AI. Maternal-preterm skin-to-skin contact enhances child physiologic organization and cognitive control across the first 10 years of life. Biol Psychiatry. 2014 Jan 1;75(1):56-64. doi: 10.1016/j.biopsych.2013.08.012. Epub 2013 Oct 4.

Scher MS, Ludington-Hoe S, Kaffashi F, Johnson MW, Holditch-Davis D, Loparo KA. Neurophysiologic assessment of brain maturation after an 8-week trial of skin-to-skin contact on preterm infants. Clin Neurophysiol. 2009 Oct;120(10):1812-8. doi: 10.1016/j.clinph.2009.08.004. Epub 2009 Sep 17.

White-Traut RC, Nelson MN, Silvestri JM, Vasan U, Littau S, Meleedy-Rey P, Gu G, Patel M. Effect of auditory, tactile, visual, and vestibular intervention on length of stay, alertness, and feeding progression in preterm infants. Dev Med Child Neurol. 2002 Feb;44(2):91-7. doi: 10.1017/s0012162201001736.

Vignochi CM, Silveira RC, Miura E, Canani LH, Procianoy RS. Physical therapy reduces bone resorption and increases bone formation in preterm infants. Am J Perinatol. 2012 Sep;29(8):573-8. doi: 10.1055/s-0032-1310520. Epub 2012 Jul 6.

Maguire CM, Walther FJ, van Zwieten PH, Le Cessie S, Wit JM, Veen S. Follow-up outcomes at 1 and 2 years of infants born less than 32 weeks after Newborn Individualized Developmental Care and Assessment Program. Pediatrics. 2009 Apr;123(4):1081-7. doi: 10.1542/peds.2008-1950.

Reproductive Health, Preterm Birth. March 23, 2012; Available from: http://www.cdc.gov/reproductivehealth/maternalinfanthealth/PretermBirth.htm.

Williams J, Lee KJ, Anderson PJ. Prevalence of motor-skill impairment in preterm children who do not develop cerebral palsy: a systematic review. Dev Med Child Neurol. 2010 Mar;52(3):232-7. doi: 10.1111/j.1469-8749.2009.03544.x. Epub 2010 Feb 4.

Botting, N., Z. Simkin, and G. Conti-Ramsden, Associated reading skills in children with a history of Specific Language Impairment (SLI). Read Writ, 2006. 19: p. 77-98.

Durkin K, Conti-Ramsden G. Language, social behavior, and the quality of friendships in adolescents with and without a history of specific language impairment. Child Dev. 2007 Sep-Oct;78(5):1441-57. doi: 10.1111/j.1467-8624.2007.01076.x.

Mulder H, Pitchford NJ, Hagger MS, Marlow N. Development of executive function and attention in preterm children: a systematic review. Dev Neuropsychol. 2009;34(4):393-421. doi: 10.1080/87565640902964524.

Pedespan L. [Attachment and prematurity]. Gynecol Obstet Fertil. 2004 Sep;32(9):716-20. doi: 10.1016/j.gyobfe.2004.06.016. French.

Quesada AA, Tristao RM, Pratesi R, Wolf OT. Hyper-responsiveness to acute stress, emotional problems and poorer memory in former preterm children. Stress. 2014 Sep;17(5):389-99. doi: 10.3109/10253890.2014.949667.

Miles MS, Holditch-Davis D, Schwartz TA, Scher M. Depressive symptoms in mothers of prematurely born infants. J Dev Behav Pediatr. 2007 Feb;28(1):36-44. doi: 10.1097/01.DBP.0000257517.52459.7a.

Zelkowitz P, Na S, Wang T, Bardin C, Papageorgiou A. Early maternal anxiety predicts cognitive and behavioural outcomes of VLBW children at 24 months corrected age. Acta Paediatr. 2011 May;100(5):700-4. doi: 10.1111/j.1651-2227.2010.02128.x. Epub 2011 Jan 11.

Holditch-Davis D, Bartlett TR, Blickman AL, Miles MS. Posttraumatic stress symptoms in mothers of premature infants. J Obstet Gynecol Neonatal Nurs. 2003 Mar-Apr;32(2):161-71. doi: 10.1177/0884217503252035.

O'Hara MW, McCabe JE. Postpartum depression: current status and future directions. Annu Rev Clin Psychol. 2013;9:379-407. doi: 10.1146/annurev-clinpsy-050212-185612. Epub 2013 Feb 1.

Spinelli M, Poehlmann J, Bolt D. Predictors of parenting stress trajectories in premature infant-mother dyads. J Fam Psychol. 2013 Dec;27(6):873-83. doi: 10.1037/a0034652. Epub 2013 Nov 4.

Shah PE, Clements M, Poehlmann J. Maternal resolution of grief after preterm birth: implications for infant attachment security. Pediatrics. 2011 Feb;127(2):284-92. doi: 10.1542/peds.2010-1080. Epub 2011 Jan 17.

Woodward LJ, Bora S, Clark CA, Montgomery-Honger A, Pritchard VE, Spencer C, Austin NC. Very preterm birth: maternal experiences of the neonatal intensive care environment. J Perinatol. 2014 Jul;34(7):555-61. doi: 10.1038/jp.2014.43. Epub 2014 Mar 20.

Gray RF, Indurkhya A, McCormick MC. Prevalence, stability, and predictors of clinically significant behavior problems in low birth weight children at 3, 5, and 8 years of age. Pediatrics. 2004 Sep;114(3):736-43. doi: 10.1542/peds.2003-1150-L.

Nomura Y, Wickramaratne PJ, Warner V, Mufson L, Weissman MM. Family discord, parental depression, and psychopathology in offspring: ten-year follow-up. J Am Acad Child Adolesc Psychiatry. 2002 Apr;41(4):402-9. doi: 10.1097/00004583-200204000-00012.

Smith GC, Gutovich J, Smyser C, Pineda R, Newnham C, Tjoeng TH, Vavasseur C, Wallendorf M, Neil J, Inder T. Neonatal intensive care unit stress is associated with brain development in preterm infants. Ann Neurol. 2011 Oct;70(4):541-9. doi: 10.1002/ana.22545. Epub 2011 Oct 4.

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• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT03316547
• Other Study ID Numbers: 201601057
• First Submitted: August 15, 2017
• First Posted: October 20, 2017
• Results First Submitted: June 14, 2021
• Results First Posted: July 7, 2021
• Last Update Posted: July 7, 2021